Recall Z-0825-2012 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
| Date | Jan 20, 2012 (initiated Dec 27, 2011) |
| Status | Terminated |
| Reason | Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak |
| Root cause | Process control |
| Action | Fresenius Medical Care North America contacted customers by telephone on December 27, 2011, and sent a Customer Notification letter dated December 27, 2011, via certified mail return receipts and fax - back requested to all affected customers. Customers were instructed to examine your stock of dialyzers, and isolate and discontinue use of the before mentioned lots. If you have identified dialyzers from the recalled lots, please contact Customer Service for a Return Goods Authorization. We will pick up the product you currently have in stock and supply replacement product. All products for r |
| Quantity | 599,436 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082414 | OPTIFLUX F250NR, MODEL 0500325E Fresenius Medical Care North America, Oct 28, 2008 |